PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80048490053
Access comprehensive regulatory information for PROSTATE-SPECIFIC ANTIGEN (PSA) in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 80048490053 and manufactured by MONOBIND INC.. The registration is held by USA DIAGNOSTICA LTDA with validity until Oct 04, 2025.
This page provides complete technical specifications for 2 related devices, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including SIEMENS HEALTHCARE DIAGNOSTICS INC., ABBOTT IRELAND DIAGNOSTIC DIVISION, and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Registration Details
80048490053
25351133630201079
02330159000108
Company Information
Dates and Status
Oct 04, 2010
04/10/2025
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA TOTAL
KATAL BIOTECNOLOGICA INDÚSTRIA E COMÉRCIO LTDA
10377390090
Apr 03, 2006
PROSTATE-SPECIFIC ANTIGEN (PSA)
FIA PSA Total
GOLD ANALISA DIAGNOSTICA LTDA
80022230298
Jul 21, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
Elecsys Total PSA
Not specified
10287411221
May 02, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
Elecsys Total PSA
ROCHE DIAGNOSTICS GMBH
10287411221
May 02, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
BIOLISA PSA TOTAL
QUIBASA QUÍMICA BÁSICA LTDA
10269360364
Aug 15, 2022
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
BECKMAN COULTER INC• United States of America
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
DIASORIN ITALIA S.P.A.• Italy
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
FASTLINE FIA PSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220283
Jul 28, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
FIA PSA Total
GOLD ANALISA DIAGNOSTICA LTDA
80022230298
Jul 21, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
Not specified
80102513486
Jul 14, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513486
Jul 14, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família LIAISON® PSA II Gen
Not specified
10339840563
May 05, 2025